Registration Dossier

Administrative data

Description of key information

The oral LD50 is > 5000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There are no studies available for the inhalationl or the dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIVO-TNO
- Age at study initiation: Young
- Weight at study initiation: males 221 to 287 g and females 147 to 180 g
- Fasting period before study: overnight
- Housing: groups of five in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): no data
- Air changes (per hr): no data, a well-ventilated room
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data:
Route of administration:
oral: gavage
Vehicle:
other: Shellsol T
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v) suspension
- Amount of vehicle (if gavage): 50%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: None
- Necropsy of survivors performed: yes
:
Statistics:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
None of the rats showed any reaction upon the treatment. At the end of the observation period all treated animals looked quite healthy.
Body weight:
No data.
Gross pathology:
Macroscopic examination of the surviving rats revealed no treatment-related gross alterations.
Other findings:
No data.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 ≥ 5000 mg/kg bw
Executive summary:

10 male and 10 female were administered a 50 %{w/v} suspension of the test substance in Shellsol T.

None of the rats showed any reaction upon the treatment and no deaths occurred. At the end of the observation period all treated animals looked quite healthy. Macroscopic examination of the surviving rats revealed no treatment-related gross alterations

From the results it appeared that the LD50 is higher than 5 g/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
A K2 study is available. The result from this study is supported by another K2 study.

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The registered substance was not acutely toxic to rats when tested by the oral gavage route. Based on the pattern of use ingestion by humans is unlikely.

An acute toxicity study via the dermal route was not performed since this is scientifically unjustified, for details see above. A weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 2000 mg/kg bw for the untested organic peroxide.

An acute toxicity study via the inhalation route was not performed and can be waived according to REACH Annex VIII since exposure via this route is unlikely.

Justification for selection of acute toxicity – oral endpoint

K2:The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.  LD50 >5000 mg/kg bw, no mortalities occured.

Justification for selection of acute toxicity – inhalation endpoint

In accordance with column 2 of REACH Annex VIII, the test for acute inhalation toxicity (required in section 8.5) does not need to be conducted. Testing by the inhalation route is not appropriate since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to particles or aerosoles of an inhalable size. The vapour pressure is very low (see section 4.6). The substance is available as flakes and in powder form. For the flakes less than 1% w/w is <100 µm. For the powder 3.6% of the particles is < 100 µm of that fraction only 0.036% is <10 µm and no particles are <5 µm. Based on the low vapor pressure and particle size inhalation is not expected to be a major route of exposure. The pattern of use does not lead to the formation of particles or aerosoles of an inhalable size

Justification for selection of acute toxicity – dermal endpoint

Numerous organic peroxides have been tested in acute dermal toxicity tests (41 organic peroxides covering all chemical subgroups/families of oragnic peroxides, excluding hydroperoxides). Experimental data of all of these organic peroxides, (except hydroperoxides), show no toxic effects at dermal application up to the tested concentration limit of 2000 mg/kg bw and show for this reason an acute dermal toxicity of >2000 mg/kg bw. Therefore, a weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 2000 mg/kg bw for the untested organic peroxide.  Additional testing for such organic peroxides is therefore not required and would not be in line with animal welfare legislation.

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, the data is conclusive but not sufficient for classification.